More details

The clinical trial is currently open to six participants. My tumor is being tested for the IGF-1R marker. Once the results are back, I'll have to go back to sign another consent form, have blood work and an ECG. I should be able to start within a week or so after that. I'll receive two medications via IV once a week: A12, which blocks IGF-1R, a protein in cells that helps keep tumors alive, and temsirolimus, which attacks the protein mTOR. It will take an hour for the first infusion, then I wait an hour, then the second infusion takes 30 minutes. I don't know what type of meds they will give me prior to and following the infusion, but apparently they will be giving me something to reduce side effects.

Ah yes, the potential side effects. For A12, the likely side effects are high blood sugar (because it targets an insulin-like growth factor) and fatigue. Some of the less likely side effects: allergic reaction, decreased white cell count, anemia, weight loss, acne, vomiting, or seeing flashing lights or floaters. Some symptoms seen in people who received A12 in other studies: diarrhea, muscle spasms, chest or abdominal pain, abnormal electrial function of the heart, and my personal favorite, Posterior Leukoencephalopathy Syndrome, which are changes to the brain that show up as confusion, change in eyesight, seizures or other symptoms, which are usually reversible but in rare cases are potentially life-threatening and may lead to longterm brain damage. Yay.

For temsiroliumus, the likely side effects include nausea, diarrhea, mouth sores (Dr. Maki mentioned this one specifically), high cholesterol, and rash. Some of the less likely: high or low blood pressure, hair loss, constipation, difficulty swallowing, infection, nosebleeds, depression, cough (just what I need), insomnia, inflammation of the pancreas, change in vision, fluid buildup in the chest, and blood clot formation, especially in the legs, which can travel to the lung. Also making the rare but serious list: heart failure, kidney failure, development of fluid around the heart, bleeding into the intestines, lungs or brain, and liver failure.

Now, as my friend Kay relates, they need to tell you every potential side effect by law. That doesn't mean that any of those side effects will occur. Other than high blood sugar and mouth sores, Dr. Maki and his research assistant didn't mention any other side effects seen in the phase I trial. Still, it makes me (and Ed) nervous. They will be watching all of us closely for any side effects, and if anything happens, I can always drop out of the trial. Let's keep our fingers crossed that I don't even have the likely side effects.

After the first cycle (six weeks per cycle), we will all be scanned. The doctors will review the results and see if there are side effects that require changes to the treatment. After that, the study will be open to 20-40 other patients at MSKCC. Nationwide, they expect to enroll just over 100 participants. I will remain in the study until I drop out, the study ends, or I show progression of disease (growth in any of my tumors). The study is currently scheduled to end in 2012.

So there you have the details. I will let you know about my scan results from last Wednesday and my starting date for the trial as soon as I hear something. There is -- thankfully -- nothing on the calendar this week other than a Zometa infusion on Friday.

I hope you all enjoyed your Thanksgiving holiday and took advantage of the long weekend.